KCP PAK CONVENIENCE PACK

FDA 510(k)

FDA Class 2 ·Ophthalmic

WALLACE INTRAUTERINE INSEMINATION CATHETER

FDA 510(k)

FDA Class 2 ·Dental

SUDOSCAN

FDA 510(k)

FDA Class 2 ·Neurology

KCP PAK #2 CONVENIENCE PACK MODIFICATION

FDA 510(k)

FDA Class 2 ·Ophthalmic

KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA

FDA 510(k)

FDA Class 2 ·Ophthalmic

BladderScan Prime System

FDA 510(k)

FDA Class 2 ·Radiology

HydroMARK Breast Biopsy Site Markers

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CAPERE Thrombectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRANSPARENT ANESTHESIA FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

FaceHeart Vitals Software Development Kit (FH vitals SDK)

FDA 510(k)

FDA Class 2 ·Cardiovascular

PARTNER INFUSION SYSTEM:

FDA 510(k)

FDA Class 2 ·General Hospital

EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS

FDA 510(k)

FDA Class 2 ·General Hospital

FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)

FDA 510(k)

FDA Class 2 ·Anesthesiology

HM70 EVO Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SKORE (Colors & Flavors), SKORE (Colors)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG

FDA 510(k)

FDA Class 2 ·Immunology

Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic